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Torcon NB G06074Recalls & reported problems

Cook Incorporated · Torcon NB, Advantage Catheter · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002060746), received between Aug 19, 2019 and Aug 19, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unsealed Device Packaging” (1 report).

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Oct 21, 2019Terminated

    The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

    Z-0439-2020 · Root cause: Process change control · FDA record ↗

Most reported problems

Device problems

  • Unsealed Device Packaging1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 19, 2019Unsealed Device Packaging; Unsealed Device Packaging

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Patient problems: No Patient Involvement

    MAUDE report 8907440 ↗

Other CATHETER, INTRAVASCULAR, DIAGNOSTIC devices

All CATHETER, INTRAVASCULAR, DIAGNOSTIC devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.